FDA.reportPublic FDA data

Application 040702

Type
ANDA
Sponsor
LEADING PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDETABLET;ORAL25MGNoNo
002HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDETABLET;ORAL50MGNoNo
003HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDETABLET;ORAL12.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-028HydrochlorothiazideHydrochlorothiazideBlenheim Pharmacal, Inc.ANDACurrent
42254-055HydrochlorothiazideHydrochlorothiazideRebel Distributors CorpANDACurrent
43353-240HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-732HydrochlorothiazideHydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-733HydrochlorothiazideHydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCANDACurrent
51407-330HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEGolden State Medical SupplyANDACurrent
51407-330HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.ANDACurrent
51407-330HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.ANDACurrent
51407-330HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.ANDACurrent
51407-330HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.ANDACurrent
51407-330HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.ANDACurrent
51407-331HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEGolden State Medical SupplyANDACurrent
51407-331HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.ANDACurrent
51407-331HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.ANDACurrent
51407-331HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.ANDACurrent
51407-331HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.ANDACurrent
51407-331HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.ANDACurrent
51407-332HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEGolden State Medical SupplyANDACurrent
51407-332HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.ANDACurrent
51407-332HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.ANDACurrent
51407-332HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.ANDACurrent
51407-332HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.ANDACurrent
51407-332HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.ANDACurrent
53217-232HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEAidarex Pharmaceuticals LLCANDACurrent
63187-440HydrochlorothiazideHydrochlorothiazideProficient Rx LPANDACurrent
63187-440HydrochlorothiazideHydrochlorothiazideProficient Rx LPANDACurrent
63187-441HydrochlorothiazideHydrochlorothiazideProficient Rx LPANDACurrent
63187-441HydrochlorothiazideHydrochlorothiazideProficient Rx LPANDACurrent
64125-130HydrochlorothiazideHydrochlorothiazideExcellium Pharmaceutical Inc.ANDACurrent
64125-131HydrochlorothiazideHydrochlorothiazideExcellium Pharmaceutical Inc.ANDACurrent
67046-275HydrochlorothiazideHydrochlorothiazideContract Pharmacy Services-PAANDACurrent
67046-276HydrochlorothiazideHydrochlorothiazideContract Pharmacy Services-PAANDACurrent
67296-0613HydrochlorothiazideHydrochlorothiazideRedPharm Drug, Inc.ANDACurrent
67296-0613HydrochlorothiazideHydrochlorothiazideRedPharm Drug, Inc.ANDACurrent
68071-1736HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDENuCare Pharmaceuticals, Inc.ANDACurrent
68071-1736HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDENuCare Pharmaceuticals, Inc.ANDACurrent
68071-3215HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDENuCare Pharmaceuticals, Inc.ANDACurrent
69315-130HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDELeading Pharma, LLCANDACurrent
69315-130HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDELeading Pharma, LLCANDACurrent
69315-130HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDELeading Pharma, LLCANDACurrent
69315-130HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDELeading Pharma, LLCANDACurrent
69315-130HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDELeading Pharma, LLCANDACurrent
69315-130HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDELeading Pharma, LLCANDACurrent
69315-131HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDELeading Pharma, LLCANDACurrent
69315-131HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDELeading Pharma, LLCANDACurrent
69315-131HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDELeading Pharma, LLCANDACurrent
69315-131HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDELeading Pharma, LLCANDACurrent
69315-131HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDELeading Pharma, LLCANDACurrent
69315-131HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDELeading Pharma, LLCANDACurrent
69315-155HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDELeading Pharma, LLCANDACurrent
69315-155HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDELeading Pharma, LLCANDACurrent
69315-155HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDELeading Pharma, LLCANDACurrent
69315-155HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDELeading Pharma, LLCANDACurrent
69315-155HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDELeading Pharma, LLCANDACurrent
69315-155HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDELeading Pharma, LLCANDACurrent
70518-2540HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.ANDACurrent
70518-2540HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.ANDACurrent
70518-2540HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.ANDACurrent
70518-2540HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.ANDACurrent
70518-2666HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.ANDACurrent
70518-2666HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.ANDACurrent
70518-2666HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.ANDACurrent
70518-2666HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.ANDACurrent
71610-471HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-488HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLCANDACurrent